Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)

NCT01942395 | Terminated

• 1 other identifier: HUM00052649
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine how dietary changes affect the heart and blood vessels in patients with hypertension (high blod pressure) who have a condition called 'heart failure with preserved ejection fraction" (HFPEF). This condition is also known as "diastolic heart failure" or "heart failure with normal ejection fraction", and occurs even though the heart's pumping function is normal.

Conditions

Diastolic Heart Failure; Hypertensive Heart Disease

Keywords

Diet; Sodium; Hypertension; Potassium; Antioxidants; Congestive Heart Failure; Heart failure with normal ejection fraction; Heart failure with preserved ejection fraction

Outcome Measures

Primary Outcomes (1)

• Urinary F2-Isoprostanes

  The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14

Secondary Outcomes (7)

• 24-hour ambulatory blood pressure (mean and diurnal variation)

  The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14

• Carotid-femoral pulse wave velocity

  The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14

• Six minute walk test distance

  The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14

• Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product

  The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14

• Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)

  The change from Week 3 in Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) at Week 6, and Week 14

Study Arms (3)

DASH/Sodium-Restricted Diet Intervention

ACTIVE COMPARATOR

Each patient will eat 3 weeks of the provided DASH/SRD diet for 21 days. The diet is patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.

Behavioral: DASH/sodium-restricted diet (DASH/SRD); Behavioral: Control Diet

Control Diet Intervention

ACTIVE COMPARATOR

Patients will consume 3 weeks of a specially prepared diet that will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.

Behavioral: DASH/sodium-restricted diet (DASH/SRD); Behavioral: Control Diet

Healthy Control

NO INTERVENTION

Fifteen healthy age-matched and 10 young healthy control patients will be recruited. Age-matched healthy control subjects will undergo testing before and after 3 weeks of eating their habitual diet. Young healthy control subjects will only require 1 study visit with no dietary intervention.

Interventions

DASH/sodium-restricted diet (DASH/SRD) BEHAVIORAL

Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.

Also known as: DASH diet, sodium-restricted diet, low sodium diet, DASH-sodium

Control Diet Intervention; DASH/Sodium-Restricted Diet Intervention

Control Diet BEHAVIORAL

The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.

Control Diet Intervention; DASH/Sodium-Restricted Diet Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms and/or signs of HFPEF in the past 12 months
• Most recent LVEF ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy)
• Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml)
• History of systemic hypertension
• Willing to adhere to provided diet

You may not qualify if:

• NYHA Class IV heart failure symptoms
• Hospitalization for decompensated HF within past one month
• Uncontrolled hypertension (seated SBP ≥ 180 or DBP ≥ 110) at rest, on current antihypertensive regimen
• Changes in medical regimen for heart disease or hypertension within past 1 month, except diuretic dose adjustment (within past 1 week)
• Previous LVEF \< 40%
• Primary exercise limitation due to severe pulmonary disease
• Uninterpretable echocardiographic windows
• Worse than moderate mitral or aortic stenosis or insufficiency.
• Baseline serum potassium level \> 5.0 mmol/L or prior history of potassium \> 6.0
• Serum calcium/phosphorus product \> 50 at baseline
• Severe renal insufficiency (current estimated GFR \< 30 ml/min)
• Severe anemia (Hgb \< 9 g/dL)
• Severely uncontrolled diabetes mellitus (Hgb A1C \> 10%)
• Non-hypertension related cause of HFPEF (e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes, primary hypertrophic or restrictive cardiomyopathy)
• Primary right ventricular failure

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

  PMID: 16855265 BACKGROUND

• Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1.

  PMID: 23033371 BACKGROUND

• Al-Solaiman Y, Jesri A, Zhao Y, Morrow JD, Egan BM. Low-Sodium DASH reduces oxidative stress and improves vascular function in salt-sensitive humans. J Hum Hypertens. 2009 Dec;23(12):826-35. doi: 10.1038/jhh.2009.32. Epub 2009 Apr 30.

  PMID: 19404315 BACKGROUND

• Borlaug BA, Olson TP, Lam CS, Flood KS, Lerman A, Johnson BD, Redfield MM. Global cardiovascular reserve dysfunction in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2010 Sep 7;56(11):845-54. doi: 10.1016/j.jacc.2010.03.077.

  PMID: 20813282 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Diastolic; Hypertension; Heart Failure

Interventions

Dietary Approaches To Stop Hypertension; Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Scott L Hummel, MD MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: September 16, 2013
• Study Start: September 18, 2012
• Primary Completion: November 18, 2015
• Study Completion: February 16, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)